Quality Engineer Ii-1

The Integer Group

Not specified in the job description.
Bachelor's degree in engineering or related field
3 years relevant experience in quality engineering
Knowledge of fda regulations and iso standards
The Integer Group is seeking a Quality Engineer II to enhance their quality management efforts within the medical device industry. The role involves applying engineering principles to address quality issues, ensuring compliance with regulatory standards, and contributing to continuous improvement initiatives

Job Summary

  • The primary purpose of this position is to perform work involving general engineering methods while utilizing advanced quality tools in the medical device industry.
  • You will support regulatory inspections, monitor manufacturing compliance, and ensure complete and correct Device History Records are maintained.
  • You are expected to lead test method validations, manage non-conforming material processes, and participate in plant CAPA activities to prevent re-occurrence.

Matching Summary

Match Score: 85

The Integer Group is seeking a Quality Engineer II to enhance their quality management efforts within the medical device industry. The role involves applying engineering principles to address quality issues, ensuring compliance with regulatory standards, and contributing to continuous improvement initiatives.

Skills & Requirements

Must-have

  • Bachelor's degree in engineering or related field
  • 3 years relevant experience in quality engineering
  • Knowledge of FDA regulations and ISO standards
  • Experience with QMS and Device History Records
  • Ability to lead root cause analysis and CAPA activities

Nice-to-have

  • Strong written and oral communication skills
  • Positive can-do attitude in high-energy environments
  • Experience with continuous improvement methodologies
  • Familiarity with Microsoft Office suite
  • Collaborative mindset for cross-functional teams

Key Requirements

  • Bachelor's degree in engineering or related field
  • Minimum 3 years of relevant experience
  • Awareness of domestic and international regulations (ISO, QSR, UL)
  • Solid technical aptitude and problem-solving skills

Work Rights

Not specified

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